US breakthrough status for Novartis’ breast cancer drug

Novartis' experimental selective cyclin dependent kinase inhibitor LEE011 (ribociclib) has picked up a Breakthrough Therapy designation in the US for the treatment of certain forms of breast cancer.

The drug is being developed for use alongside letrozole for the treatment of hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer.

The award indicates the US Food and Drug Administration's belief that LEE011 could potentially offer an improvement over an available therapy on at least one clinically significant endpoint, and is designed to help speed up its regulatory pathway to ensure quicker access for patients.

The decision came after data from the Phase III MONALEESA-2 trial, involving postmenopausal women who had received no prior therapy for their advanced disease, showing an improvement in progression free survival in those taking the drug.

Full results of the study are to presented at an upcoming medical congress and will form the basis of regulatory discussions in the US, Europe and other countries for use in this indication, Novartis said.

"Despite advancements in treatment, an estimated 40,000 individuals in the United States die each year from advanced breast cancer," said Alessandro Riva, MD, Global Head, Oncology Development and Medical Affairs, Novartis Oncology.

"This designation shows the potential of LEE011, and we look forward to close collaboration with the FDA and the advanced breast cancer community to provide a new treatment option for women living with HR+/HER2- advanced breast cancer as quickly as possible."